Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods

January 31, 2018 updated by: Dr. Martin Leitritz, University Hospital Tuebingen

Self evaluating tools based on smartphone devices are public available on the market for each person. The tools are used to estimate the existing refractive error for each eye of a patient. Hereafter, e.g. ordering glasses via internet could be the next step for this persons.

The daily routine within an eye hospital shows, that estimation of the refractive error is a difficult and time consuming procedure.

The study compares the results of the measured refractive error using a smartphone based tool with the results of conventional measurement methods.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tuebingen, BW, Germany, 72076
        • Recruiting
        • University Eye Hospital
        • Contact:
        • Principal Investigator:
          • Martin A Leitritz, M.D.
        • Sub-Investigator:
          • Sebastian Mueller, M.D.
        • Principal Investigator:
          • Markus Schulze-Schwering, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • existing refractive error
  • using glasses or contac lenses

Exclusion Criteria:

  • opacities (visus limitating) of cornea, lens or vitreous
  • known ocular pathologies except refractive error
  • epilepsia
  • irregular corneal topography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Main group
Main study group including all individuals that underwent the study procedures
Diagnostic test: Smartphone
Smartphone based measurement of refractive error and visual acuity testing using these measurements.
Diagnostic test: Autorefractor
Autorefractor based measurement of refractive error and visual acuity testing using these measurements.
Diagnostic test: Individual
Individual, human measurement of refractive error and visual acuity testing using these measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refractive Error
Time Frame: 6 month
Comparison of refractive error measurements between methods
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 6 month
Visual acuity of persons using based on different methods.
6 month
Personal evaluation of measuring accuracy (Questionnaire)
Time Frame: 6 month
Would persons be willing to order glasses by using only self-test-results?
6 month
Time consumption
Time Frame: 6 month
Comparison of needed time to reach self-test refraction error results and conservative-test results.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Anticipated)

January 31, 2018

Study Completion (Anticipated)

March 31, 2018

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • smart-glass

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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